Department of Gastroenterology and Hepatology, Saiseikai Nakatsu Hospital, 2-10-39 Shibata Kita-ku, Osaka, 530-0012, Japan.
Department of Pharmacy, Shimane University Hospital, 89-1 Enyacho, Izumo, Shimane, 693-0021, Japan.
Dig Dis Sci. 2019 Mar;64(3):823-831. doi: 10.1007/s10620-018-5377-9. Epub 2018 Nov 21.
Approximately 30% of patients who are treated with proton pump inhibitors (PPIs) for gastroesophageal reflux disease (GERD) experience persistent symptoms. No prokinetic agent regiments are useful for symptom relief.
This study was conducted to examine the effect of adding acotiamide to PPI or vonoprazan refractory GERD.
This was a randomized, prospective, double-blind, placebo-controlled trial. Seventy-one patients were enrolled. Patients underwent upper endoscopy before initial therapy [15 reflux esophagitis and 55 non-erosive reflux disease (NERD)]. Patients with persistent reflux symptoms were administered 300 mg/day acotiamide or placebo for 2 weeks. The primary endpoint was overall treatment effect (OTE), and gastrointestinal symptoms were evaluated. High-resolution manometry (HRM) and 24-h multiple intraluminal impedance-pH (MII-pH) monitoring were conducted before and after treatment when possible.
Seventy patients were randomized (35 acotiamide and 35 placebo). Sixteen and 10 patients in the acotiamide and placebo groups, respectively, completed MII-pH and HRM. The OTE improvement rates were 28.6% and 14.3% in patients administered acotiamide and placebo, respectively (p = 0.145). In patients with NERD, however, the OTE improvement rate and responder rate for regurgitation in the acotiamide group was significantly higher than those in the placebo group (29.6 vs. 7.1%; p = 0.030, 37.0 vs. 10.7%; p = 0.021, respectively). Acotiamide significantly reduced the total reflux episodes (p = 0.001), acid (p = 0.020), proximal reflux (p = 0.007), and liquid reflux (p = 0.013) episodes.
Adding acotiamide to gastric acid inhibitors can improve symptoms in patients with refractory NERD.
约 30%接受质子泵抑制剂（PPI）治疗胃食管反流病（GERD）的患者持续存在症状。没有促动力药物可用于缓解症状。
本研究旨在研究添加阿考替胺治疗 PPI 或 vonoprazan 难治性 GERD 的效果。
这是一项随机、前瞻性、双盲、安慰剂对照试验。共纳入 71 例患者。所有患者在初始治疗前均接受上消化道内镜检查[15 例反流性食管炎和 55 例非糜烂性反流病（NERD）]。持续存在反流症状的患者接受 300mg/d 阿考替胺或安慰剂治疗 2 周。主要终点为整体治疗效果（OTE），并评估胃肠道症状。在可能的情况下，治疗前后进行高分辨率测压（HRM）和 24 小时多腔内阻抗-pH（MII-pH）监测。
70 例患者被随机分为阿考替胺组（35 例）和安慰剂组（35 例）。阿考替胺组和安慰剂组分别有 16 例和 10 例患者完成了 MII-pH 和 HRM 检查。阿考替胺组和安慰剂组的 OTE 改善率分别为 28.6%和 14.3%（p=0.145）。然而，在 NERD 患者中，阿考替胺组的 OTE 改善率和反流症状应答率显著高于安慰剂组（29.6% vs. 7.1%；p=0.030，37.0% vs. 10.7%；p=0.021）。阿考替胺可显著减少总的反流事件（p=0.001）、酸反流（p=0.020）、近端反流（p=0.007）和液体反流（p=0.013）事件。
在胃酸抑制剂中添加阿考替胺可改善难治性 NERD 患者的症状。
